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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DATEX-OHMEDA, INC. AVANCE ANESTHESIA GAS MACHINE

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DATEX-OHMEDA, INC. AVANCE ANESTHESIA GAS MACHINE Back to Search Results
Device Problem Display or Visual Feedback Problem (1184)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/04/2022
Event Type  malfunction  
Manufacturer Narrative
The distributor performed a checkout of the equipment and confirmed the reported issue. The lcd display was replaced which the distributor reported corrected the issue. No report of patient involvement. The initial reporter is located outside the u. S. , and therefore this information is not provided due to country privacy laws. Legal manufacturer: hcs madison - (b)(6). The distributor performed a checkout of the equipment and confirmed the reported issue. The lcd display was replaced which the distributor reported corrected the issue. No report of patient involvement. The initial reporter is located outside the u. S. , and therefore this information is not provided due to country privacy laws. Legal manufacturer: hcs madison: (b)(6).
 
Event Description
The customer reported a malfunction resulting in the loss of display. There was no report of patient involvement.
 
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Brand NameAVANCE
Type of DeviceANESTHESIA GAS MACHINE
Manufacturer (Section D)
DATEX-OHMEDA, INC.
3030 ohmeda dr,
madison, WI 53718
Manufacturer (Section G)
DATEX-OHMEDA, INC.
3030 ohmeda dr,
madison, WI 53718
Manufacturer Contact
anthony amenson
3030 ohmeda drive
madison, WI 53718
MDR Report Key15138913
MDR Text Key301116412
Report Number2112667-2022-02550
Device Sequence Number1
Product Code BSZ
Combination Product (y/n)N
Reporter Country CodeKS
PMA/PMN Number
K172045
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,User Facility,Distributor
Reporter Occupation Biomedical Engineer
Type of Report Initial
Report Date 08/01/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/01/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received07/04/2022
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured10/26/2010
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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